Food additive delisting: Seven synthetic flavoring substances scrapped in US amid carcinogen concerns

08 Oct 2018 --- A batch of synthetic flavoring substances and flavor enhancers have been removed from the Food Additives List. The US Food & Drug Administration (FDA) is amending its food additive regulations in response to two food additive petitions, to no longer allow for the use of six flavoring substances. These include the synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone and pyridine. The seventh synthetic flavor, styrene, is being delisted but it has already been abandoned, according to the agency and is no longer used by industry.

The FDA determined that the data presented in one of the petitions show that six of these synthetic substances caused cancer in laboratory animals under the conditions of the studies. 

The food industry has been given two years to reformulate their products to eliminate six of the seven chemicals.

These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This clause, enacted in 1958, requires that the FDA cannot find as safe; i.e., cannot approve, the use of any food additive that has been found to induce cancer in humans or animals at any dose.

“Although we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use,” says the FDA.

“The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the US marketplace in very small amounts and their use results in very low levels of exposures and low risk.”

“While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.”

Each of these synthetic substances has a natural counterpart in food or natural substances used to flavor foods. The FDA’s revocation of the listings providing for the use of these synthetic flavoring substances and adjuvants does not affect the legal status of foods containing their natural counterparts or of flavoring substances extracted from such food, often labeled as “natural flavors.”

Based on the evidence presented by the petitioners that benzophenone causes cancer in animals, the FDA also is amending the food additive regulations to no longer provide for its use as a plasticizer in rubber articles intended for repeated use in contact with food.

The petition was submitted to the FDA by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids’ Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and James Huff.

In response to a separate food additive petition from the Styrene Information and Research Center, the FDA is also amending its food additive regulations to no longer allow for the use of styrene as a synthetic flavoring substance and adjuvant because the industry has abandoned this use. 

“For the other six synthetic flavoring substances, the FDA will provide 24 months from the publication of the rule in the Federal Register for companies to identify suitable replacement ingredients and reformulate their food products,” continues the FDA.

Laura MacCleery, Policy Director at the consumer lobby group Center for Science in the Public Interest (CSPI) says the Food and Drug Administration’s decision to remove the synthetic flavorings, variously used in drinks, candy, ice cream, and other foods, from its list of approved food additives, is an “important victory for consumer confidence.”

“The move is in response to a 2016 petition filed by Environmental Defense Fund, Natural Resources Defense Council, CSPI, and other organizations, and a subsequent lawsuit to prompt an agency response that was filed on our behalf by Earthjustice earlier this year,” she says. “The flavorings were listed by FDA as safe to use in food in the 1960s, based on the science then available to the agency.”

“Since that time, they had been tested and determined to have evidence of carcinogenicity by FDA’s sister agency, the National Toxicology Program. By law, FDA is required to withdraw approvals for the use of a substance where there is evidence that the substance is a carcinogen,” she notes.